CTRI/2016/05/006957进行中（未招募）4 期
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS) - CoreValveTM India (PMS)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patients with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure and with anatomy appropriate for the 23, 26, 29 or 31 mm valve system who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.
- •Indications and contraindications are provided in the product Instructions for Use.
- •Subject is scheduled to receive transcatheter aortic valve
- •Subject is 18 years of age or older
- •The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the PMS and the Informed consent for both Audio Visual (AV) recording and for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements in India
排除标准
- 未提供
研究者
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